Drug recall
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
FDA recall event 90691 · Class II · Qiagen Sciences LLC
Key facts
| Event ID | 90691 |
|---|---|
| Recall numbers | Z-1650-2022, Z-1651-2022, Z-1652-2022 |
| Recalling firm | Qiagen Sciences LLC |
| Product type | Devices |
| Products | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010, therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711, therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to… |
| Initiation date | Jul 20, 2022 |
| Report date | Sep 7, 2022 |
| City | Germantown |
| State | MD |
| Country | United States |
| FEI number | 3003572099 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: